Atrial FibrillationNCT02721121
Comparison of Circumferential Pulmonary Vein Isolation Alone Versus Linear Ablation in Addition to Circumferential Pulmonary Vein Isolation for Catheter Ablation in Persistent Atrial Fibrillation: Prospective Randomized Controlled Trial
A study testing circumferential pulmonary vein isolation and Linear ablation in addiction to circumferential pulmonary vein isolation in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the clinical outcomes depending on catheter ablation strategy for persistent atrial fibrillation. After randomization, investigators will conduct circumferential pulmonary vein isolation alone in a group, and additional posterior box isolation and anterior linear ablation in the… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- circumferential pulmonary vein isolation and Linear ablation in addiction to circumferential pulmonary vein isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with persistent Atrial fibrillation (20~80 years)
- LA diameter <55mm
- patients possible to anticoagulation and anti arrhythmic drug
Who cannot join
- Structural cardiac disease
- Contraindication to brain perfusion CT
- Catheter ablation history for AF,
- Cardiac surgery for AF
- active internal bleeding
- Impossible to anticoagulation or antiarrhythmic drug
Show all 10Show fewer
- valvular AF (MA> GII, Mechanical valve, Mitral valve replacement)
- Patients with severe medical disease
- Expected survival < 1year
- Severe alcoholics, drug addiction
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, 120-752
Hui-Nam Pak, M.D., Ph.D., 82-2-2228-8459, hnpak@yuhs.ac
About this study
The purpose of this study is to compare the clinical outcomes depending on catheter ablation strategy for persistent atrial fibrillation. After randomization, investigators will conduct circumferential pulmonary vein isolation alone in a group, and additional posterior box isolation and anterior linear ablation in the other group. Investigators will compare clinical recurrence rate, complication rate, and procedure time, etc.
- Conditions
- Atrial Fibrillation
- Being tested
- circumferential pulmonary vein isolation, Linear ablation in addiction to circumferential pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circumferential pulmonary vein isolationProcedure or surgery
Linear ablation in addiction to circumferential pulmonary vein isolationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| circumferential pulmonary vein isolation | Active comparator | circumferential pulmonary vein isolation Receives: Procedure: circumferential pulmonary vein isolation |
| Linear ablation in addiction to pulmonary vein isolation | Experimental | Linear ablation in addiction to pulmonary vein isolation Receives: Procedure: Linear ablation in addiction to circumferential pulmonary vein isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of atrial fibrillation after catheter ablation
Measured: 12 month
Secondary outcomes (3)
procedure time
Measured: 1 day
procedure related complication rate
Measured: 12 month
rate of hospitalization
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721121
- Sponsor's protocol ID
- 4-2016-0029
- Status last verified
- Jan 2019
- First submitted
- 22 Mar 2016
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lee JM, Shim J, Park J, Yu HT, Kim TH, Park JK, Uhm JS, Kim JB, Joung B, Lee MH, Kim YH, Pak HN; POBI-AF Investigators. The Electrical Isolation of the Left Atrial Posterior Wall in Catheter Ablation of Persistent Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Nov;5(11):1253-1261. doi: 10.1016/j.jacep.2019.08.021. Epub 2019 Oct 30.
PubMed 31753429
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Circumferential Pulmonary Vein Isolation Alone Versus Linear Ablation in Addition to Circumferential Pulmonary Vein Isolation for Catheter Ablation in Persistent Atrial Fibrillation: Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02721121
- Acronym / sponsor ID
- 4-2016-0029
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 28 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the clinical outcomes depending on catheter ablation strategy for persistent atrial fibrillation. After randomization, investigators will conduct circumferential pulmonary vein isolation alone in a group, and additional posterior box isolation and anterior linear ablation in the other group. Investigators will compare clinical recurrence rate, complication rate, and procedure time, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| circumferential pulmonary vein isolation | Active comparator | Procedure: circumferential pulmonary vein isolationcircumferential pulmonary vein isolation |
| Linear ablation in addiction to pulmonary vein isolation | Experimental | Procedure: Linear ablation in addiction to circumferential pulmonary vein isolationLinear ablation in addiction to pulmonary vein isolation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with persistent Atrial fibrillation (20~80 years)
- LA diameter <55mm
- patients possible to anticoagulation and anti arrhythmic drug
Key exclusion criteria (10 listed)
- Structural cardiac disease
- Contraindication to brain perfusion CT
- Catheter ablation history for AF,
- Cardiac surgery for AF
- active internal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| circumferential pulmonary vein isolation | Procedure or surgery | circumferential pulmonary vein isolation |
| Linear ablation in addiction to circumferential pulmonary vein isolation | Procedure or surgery | Linear ablation in addiction to pulmonary vein isolation |
Primary outcome
Recurrence of atrial fibrillation after catheter ablation
Time frame: 12 month
3 secondary outcomes
procedure time
Time frame: 1 day
procedure related complication rate
Time frame: 12 month
rate of hospitalization
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Derived from this study: PubMed 31753429Lee JM, Shim J, Park J, Yu HT, Kim TH, Park JK, Uhm JS, Kim JB, Joung B, Lee MH, Kim YH, Pak HN; POBI-AF Investigators. The Electrical Isolation of the Left Atrial Posterior Wall in Catheter Ablation of Persistent Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Nov;5(11):1253-1261. doi: 10.1016/j.jacep.2019.08.021. Epub 2019 Oct 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing circumferential pulmonary vein isolation and Linear ablation in addiction to circumferential pulmonary vein isolation in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of atrial fibrillation after catheter ablation (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02721121, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.